Go Behind the AHRQ/NIH Study Section Door

1. Go Behind the AHRQ/NIH Study Section Door A Mock Review

2. The Panel • Linda Greenberg, PhD • Willard Manning, PhD • Ming Tai-Seale, PhD

3. The Agenda • Relevant funding mechanisms: Rs, Ks • Life of a proposal • Scientific review: who, where, how • Critical areas for improvement • Mock review • Summary statement • How to work with federal officials • Questions and answers

4. Funding Mechanisms Linda

5. Rxx • GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH (R36) • Support students seeking a doctorate • after successful dissertation defense • in areas relevant to health services research • Total direct costs <$30,000 • R01, R03, …

6. Relevant Funding Mechanisms: K01, K02, K08, … • Mentored Clinical Scientist Development Award (K08) • Development of outstanding research scientists. • Specialized study support for trained professionals who are committed to a career in research and have the potential to develop into independent investigators • Focuses on progression to independence • Study and development consistent with his/her needs, and previous research or clinical experience. • The proposed length of the award must be well explained and justified • Support will only be provided for the period deemed necessary to achieve independence

7. The Life of a Proposal Ming

9. Disciplines Anthropology Biostatistics Economics Epidemiology Health services research Medicine Nursing Organizational Theory Sociology Methodological Orientations Quantitative Qualitative Mixed Stages in Their Own Careers Senior Scholars Emergent scientists Who Serve on Study Sections?

11. Where is the Review Done • NIH • AHRQ • Let’s go there …

12. The Physical Setting

13. Applicant must address: Risks to human subjects Adequacy Summary reviewer choices: Human subjects NOT involved Human subjects involved, ACCEPTABLE Human subjects involved, UNACCEPTABLE Human subjects involved, exemption claimed Protection of Human Subjects

14. Gender Code: First Character = G 1= Both Gender 2= Only Women 3= Only Men 4= Gender Unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Minority Code: First character = M Second character: 1=Minority and Nonminority 2= Only Minority 3= Only Nonminority 4= Minority unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Inclusion of Women and Minorities

15. Inclusion of AHRQ Priority Populations Checklist Adequate numbers for sub-group analysis? For excluded, including rationale?

16. Gender Code: First Character = G 1= Both Gender 2= Only Women 3= Only Men 4= Gender Unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Minority Code: First character = M Second character: 1=Minority and Nonminority 2= Only Minority 3= Only Nonminority 4= Minority unknown Third Character: A= Scientifically acceptable U= Scientifically unacceptable Inclusion of Women and Minorities

17. Adjectives Used in Review 1.0-1.5 Outstanding 1.6-2.0 Excellent 2.1-2.5 Very Good 2.6-3.5 Good 3.6-5.0 Acceptable

18. Priority Score • How is the summary priority score calculated? • Group average • Equal weight • What is the fundable range? • Study sections can have different norms • When in doubt, ask the project officer

19. Critical Areas for Improvementfor K0x Will

20. Critical Areas for Improvementfor K0x • It Is Not About • 5 years of support • 75 percent buyout • $$$

21. It Is About • Mentored • Clinical Scientist • Development

22. It Is About (cont’d) • It does require mentoring • It is about career development for researchers • Not just about more education • Not just about doing preliminary studies • Don’t confuse K with series of R03’s

23. Disconnected Mentor • Mentor’s letter not closely tied to content of proposal. • Mentor’s letter written by proposer and it looks like it. • Mentor approached with proposal with only week left before due date. • Little impact on proposal. • Worse if proposal is naïve.

24. Distant Mentor • Always very hard to sell. • Study section distrusts supposed level of commitment by mentor. • Plans for linkage, visiting vague.

25. Who is in charge? • Too many mentors • No strong primary • Nobody with oversight responsibility

26. Career Development Plan • R-Avoidance • Its thinly disguised research support for 5 years. • Little or no education component. • A La Carte Education: • Lacks coherent rationale for what’s proposed. • Need to lay out individual strengths and weaknesses. • It’s OK to say you’re imperfect!!!

27. Career Development Plan • Educational elements too vague • Visiting Prof. Jones T times per year. T small. • Lack of specificity • Not clear depth of training • Formal course work preferred • if a good match for needs. • if level appropriate • Avoid lower level MPH courses.

28. Critical Areas for Improvement in Rs • Design problem • Measurement • Choice of variables • Intervention/comparison • Analysis problem • Choice of approach • Technique • Test

29. Critical Areas for Improvement in Rs • Weak justification for study • Background and significance unconvincing • Literature review incomplete • Investigator expertise deficient • Needs consultants or collaborators • Theoretical or conceptual model or framework • Missing, deficient, or erroneous

32. Mock Review • Chair: Willard Manning, PhD • Primary: Ming Tai-Seale, PhD • Secondary: Willard Manning, PhD Usually there is a tertiary reviewer • K08 – Mentored Clinical Scientist Development Award

33. Review Guideline • Candidate • Career development plan • Research plan • Mentor/co-mentor • Environment and institutional commitment • Budget • Human subjects • Women/minorities/children • SUMMARY • major strengths and weaknesses • Recommendation for or against funding

34. Summary Statement Ming

35. How to Read the Pink Sheet • Expect the language to be • Frank, and • Not overly enthusiastic • Be emotionally detached, after the initial… • Talk to an experienced grant-maker • Resubmit unless you see “fatally flawed” • Do NOT resubmit right away • Recruit a “cold reviewer”

36. Take a Vacation …

37. Role of Federal Officials Linda

38. What Can You Expect From • Project officers • Read your concept paper and draft • Send it in EARLY! • Interpret the fundability of your priority score • Scientific review administrators • Assign reviewers who may have expertise to review your proposal

39. Questions & AnswersPanel

40. Resources • Video on Peer Review for Clinical Research • http://www.csr.nih.gov/Video/Video_print.asp • Instructions on how to prepare your application • http://grants.nih.gov/grants/funding/phs398/section_1.html • Our contact information • Linda: linda.greenberg@ahrq.hhs.gov • Will: w-manning@uchicao.edu • Ming: mtaiseale@srph.tamhsc.edu • Can’t comment on any current proposal in the review process